RAE Versus MIE in Patients With Esophageal Cancer After Neoadjuvant Therapy

Launched by SHANGHAI CHEST HOSPITAL · Aug 21, 2023

Keywords

ClinConnect Summary

This clinical trial is designed to compare two surgical methods for treating patients with locally advanced esophageal cancer who have already received initial therapy, such as chemotherapy or radiation. The two methods being studied are called RAMIE (Robot-Assisted Minimally Invasive Esophagectomy) and MIE (Minimally Invasive Esophagectomy). Researchers want to find out if the long-term survival rates for patients undergoing RAMIE are just as good as those for MIE, which has been shown to be effective in previous studies. This trial will involve about 260 patients from our hospital, and it will follow strict guidelines to ensure safety and ethical conduct.

To be eligible for the trial, participants should be between 18 and 75 years old and have a specific type of esophageal cancer located within the chest area. They should have received prior treatment but should not have any other active cancers or have participated in other studies during this time. If someone joins the trial, they will receive one of the two surgical treatments and will be monitored for their recovery and long-term health outcomes. The trial is currently not recruiting participants, but it's an important step in finding the best treatment options for esophageal cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ranges from 18 to 75 years;
• • 2. European Clinical Oncology Group Performance Status (ECOG PS) 0-2;
• • 3. Histological subtype of esophageal squamous cell carcinoma;
• • 4. Primary tumors are located at the intrathoracic esophagus;
• • 5. Pre-treatment stage as cT1b-4aN1-3M0, cT3N0M0 (AJCC/UICC 8th Edition);
• • 6. With neoadjuvant chemoradiotherapy, chemotherapy and immunotherapy;
• • 7. Without any anticancer therapy for other malignant diseases;
• • 8. Written informed consent.
• Exclusion Criteria:
• • 1. Cervical esophageal cancer and carcinoma of gastro-esophageal junction;
• • 2. Patients with unresectable or metastatic esophageal cancer;
• • 3. Histological subtype of esophageal non-squamous cell carcinoma;
• • 4. History of previous thoracic surgery;
• • 5. Patients with other malignant tumor (previous or current);
• • 6. Participation in another clinical trial during this study.